Data Transparency Consultant

5 days ago


Canton, Michigan, United States MMS Full time
Company Overview
MMS is a leading clinical research organization (CRO) that provides data-focused services to the pharmaceutical, biotech, and medical device industries. Our company is recognized for its exceptional culture and industry best employee retention rate, making us a Great Place to Work certified organization.

We pride ourselves on our innovative approach to complex trial data and regulatory submission challenges, with a proven track record of success across four continents. With an industry-leading customer satisfaction rating, we foster a collaborative and inclusive work environment where employees can thrive.

Job Description
The Senior Transparency Specialist will provide operational support in the following areas:
  • Clinical Trial Transparency
  • Clinical Trial Data Sharing
  • Redaction and anonymization of clinical trial documents in accordance with evolving global regulations

Responsibilities:
  • Responsible for providing high-quality transparency deliverables in an efficient manner.
  • Technical expertise on regulatory requirements (EMA Policy 0070, HC PRCI, EU-CTIS etc.).
  • Facilitates the initiation, progression and completion of the exchange of information for all Transparency workflow steps, with skill and proficiency.
  • Performs quality control reviews of document redaction or anonymization to ensure consistency and accuracy.
  • Maintain a strong understanding of regulations and guidance's as they pertain to transparency; ensure deliverable timelines are compliant with regulatory timelines.
  • Lead projects with minimal management oversight, including complex projects with multiple team members; coordination independently with the client.
  • Tailors communication to diverse audience considering experience, background, and expectations.
  • Anticipate and understand customer's needs and preferences and can provide solutions to customer's needs; Develops deliverables according to customer specifications.
  • Effectively manage/ prioritize multiple deliverables and delegate as needed or implement workable solutions to complete deliverables on time.
  • Capable of leading Transparency process/tools improvements initiatives and may participate in complex companywide process improvement initiatives.
  • Facilitates and fosters positive team environment while supporting independent action to achieve team goals.
  • Experience with identifying CCI a plus.


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